Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643500

Enrollment

342

Registered

2008-03-26

Start date

2002-01-31

Completion date

2003-05-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Partial

Keywords

Levetiracetam, Keppra

Brief summary

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study * to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development * to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Interventions

DRUGLevetiracetam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female older than 16 years; * Epilepsy with partial onset seizures, with or without secondary generalization; * At least one concomitant marketed anti-epileptic drug

Exclusion criteria

* Safety reasons

Design outcomes

Primary

Measure	Time frame
Adverse event rates, seizure counts and quality of life.	16 week treatment period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026